Cost planning for oncological therapies from the clinic's point of view regarding clinical care and studies [Kostenplanung onkologischer Therapien aus Sicht der Klinik im Rahmen klinischer Versorgung und Studien]

General conditions for performing medical and oncological care in Germany Providing health care in any country reflects the country's legal system and financial resources. The entire medical system in Germany is in a constant change from a cost-unaware social affair institution to an economic market-based health care supplier. This is an extended and continuing process in which physicians have to weight economics, ethics, and demands of all stakeholders against each other and learn to prioritize use of resources. The goal of a comprehensive economy-oriented heath care is intended by the majority of politicians and parties in Germany and enforced by the implementation of flat rate ambulatory and Diagnosis-Related Groups (DRG) in-patient reimbursements. Multiple types of budget caps, insufficient flat rate reimbursements, payback of reimbursement as regress for pharmaceutical off-label use, federal-administered prices for heath care, self-coverage by hospitals for cost of patients' complications, non-reimbursement for expensive pharmaceuticals used for in-patients, etc. are just a few of the problems any physician has to face and solve daily. In contract to public believe the financial risk of diseases and medical care is not with any health insurance or sickness funds but with the heath care providing physician and/or his/her employer. This results in a politically intended rationing of health care from optimal to minimal standards. According to the German Social Law Book V (SGB V) §12 medical care has to be acceptable, suitable and economically and should not exceed the necessary care. This is in contrast and in a remarkable contradiction to guideline standards which are demanded by patients and health insurances and continuously expanded by all health market stakeholders. But guideline-based treatment is not financially calculated and therefore not reflected in its reimbursement which can result in a financial loss and even bankruptcy for the providing physician or institution. A yearly over proportionally increase of costs above the inflation rate for innovative oncological pharmaceuticals and care has resulted in the need for active measures to comply with economic rules by hospital to financially survive and still provide oncology at state-of-the-art level without reducing standard of care. Current reimbursement rules for oncological therapies are complex and at least partially contradictive and do not provide a fair and adequate reimbursement. Pitfal